Veteran Owned Business


Why Freije Quality Engineering?

John Freije, CQE, CMfgT is the President and Principal Consultant at Freije Quality Engineering, LLC.  In this capacity John works with medical device companies and suppliers to medical device companies to develop and implement Quality Systems that exceed the expectation of ISO 13485 and FDA’s Quality System Regulation 21 CFR 820.

John brings to the table over 30 years experience working for the government and the private sector, with over 20 years in the medical device and pharmaceutical industries.  John has held several positions with increasing responsibility at Roche Diagnostics, Eli Lilly & Co., Raytheon Technical Services, and the US Army.

Examples of Past Successful Projects

Developed and implemented supplier audit program

Successful commercialization of a new insulin pen-injector

Led Design Controls effort for new infusion pump selectable flow controller, including Human Factors evaluations and 510(k) preparation, which resulted in a successful launch three months prior to plan

Provided quality assurance for an insulin combination product

Successful implementation of ISO 13 485 compliant quality systems for medical device suppliers

Provide ongoing Process Validation guidance/support to a plastic injection supplier to the orthopedics industry

Conduct sterile barrier packaging validations

Leading companies through Notified Body audits and FDA inspections